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Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

Primary Purpose

Plantar Fascitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention + Standard of care
Standard of care
Sponsored by
brett rasmussen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring Plantar fasciosis, acupuncture, electrostimulation, primary care

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

**Patients must be able to get care at Nellis Air Force Base, Scott Air Force Base, or Eglin Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

  • Male and female DoD beneficiaries, aged 18 to 74 years, who have been diagnosed with plantar fasciosis (in one or both of their feet) OR
  • Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning & tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts).

Those with acute and chronic diagnoses will be included.

Exclusion Criteria:

  • Pregnant
  • Any of the following in the foot being included into the study:

    • Active cellulitis of lower extremity
    • Prior surgery for plantar fasciosis
    • Steroid injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subjects will be offered to be involved in the study after they have completed a 12 -week wash out period.
    • If they have every had any prior acupuncture for plantar fasciosis using the defined Deep Ankle Local Periosteal points, any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12-week wash out period.
    • Botox injections for plantar fasciosis injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed.

Sites / Locations

  • 96th Medical Group
  • Scott AFB
  • Mike O'Callaghan Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention + Standard of care

Standard of care

Arm Description

Acupuncture with electrostimulation plus standard of care prescribed home exercise program.

Standard of care prescribed home exercise program.

Outcomes

Primary Outcome Measures

Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Defense and Veterans Pain Rating Scale Supplemental Questions
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Defense and Veterans Pain Rating Scale Supplemental Questions
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Defense and Veterans Pain Rating Scale Supplemental Questions
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Defense and Veterans Pain Rating Scale Supplemental Questions
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Defense and Veterans Pain Rating Scale Supplemental Questions
For clinicians to evaluate the biopsychosocial impact of pain.
Foot function index revised short (FFI-R short)
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Foot function index revised short (FFI-R short)
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Foot function index revised short (FFI-R short)
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Foot function index revised short (FFI-R short)
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Foot function index revised short (FFI-R short)
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2020
Last Updated
January 13, 2022
Sponsor
brett rasmussen
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1. Study Identification

Unique Protocol Identification Number
NCT04243343
Brief Title
Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis
Official Title
A Randomized, Controlled, Multi-site Trial of a Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
brett rasmussen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Determine if the addition of a specific acupuncture protocol to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.
Detailed Description
This is a randomized, controlled, multi-site trial investigating whether a specific acupuncture protocol can improve pain and function in adults with plantar fasciosis when added to standard of care treatment. The investigators hypothesize that there will be a significant improvement in both pain and functional outcomes, both acutely and over time, in the experimental group compared to the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
Plantar fasciosis, acupuncture, electrostimulation, primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention + Standard of care
Arm Type
Experimental
Arm Description
Acupuncture with electrostimulation plus standard of care prescribed home exercise program.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care prescribed home exercise program.
Intervention Type
Device
Intervention Name(s)
Intervention + Standard of care
Intervention Description
Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care prescribed home exercise program for treatment of plantar fasciosis.
Primary Outcome Measure Information:
Title
Defense and Veterans Pain Rating Scale (DVPRS)
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Time Frame
visit 1 (Day 1)
Title
Defense and Veterans Pain Rating Scale (DVPRS)
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Time Frame
visit 2 (week 2)
Title
Defense and Veterans Pain Rating Scale (DVPRS)
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Time Frame
visit 3 (week 4)
Title
Defense and Veterans Pain Rating Scale (DVPRS)
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Time Frame
visit 4 (week 6)
Title
Defense and Veterans Pain Rating Scale (DVPRS)
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used
Time Frame
visit 5 (week 12)
Title
Defense and Veterans Pain Rating Scale Supplemental Questions
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Time Frame
visit 1 (Day 1)
Title
Defense and Veterans Pain Rating Scale Supplemental Questions
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Time Frame
visit 2 (week 2)
Title
Defense and Veterans Pain Rating Scale Supplemental Questions
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Time Frame
visit 3 (week 4)
Title
Defense and Veterans Pain Rating Scale Supplemental Questions
Description
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.
Time Frame
visit 4 (week 6)
Title
Defense and Veterans Pain Rating Scale Supplemental Questions
Description
For clinicians to evaluate the biopsychosocial impact of pain.
Time Frame
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. visit 5 (week 12)
Title
Foot function index revised short (FFI-R short)
Description
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Time Frame
visit 1 (Day 1)
Title
Foot function index revised short (FFI-R short)
Description
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Time Frame
visit 2 (week 2)
Title
Foot function index revised short (FFI-R short)
Description
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Time Frame
visit 3 (week 4)
Title
Foot function index revised short (FFI-R short)
Description
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Time Frame
visit 4 (week 6)
Title
Foot function index revised short (FFI-R short)
Description
FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.
Time Frame
visit 5 (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
**Patients must be able to get care at Nellis Air Force Base, Scott Air Force Base, or Eglin Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Male and female DoD beneficiaries, aged 18 to 74 years, who have been diagnosed with plantar fasciosis (in one or both of their feet) OR Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning & tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts). Those with acute and chronic diagnoses will be included. Exclusion Criteria: Pregnant Any of the following in the foot being included into the study: Active cellulitis of lower extremity Prior surgery for plantar fasciosis Steroid injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subjects will be offered to be involved in the study after they have completed a 12 -week wash out period. If they have every had any prior acupuncture for plantar fasciosis using the defined Deep Ankle Local Periosteal points, any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12-week wash out period. Botox injections for plantar fasciosis injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F Crawford, MD
Organizational Affiliation
United States Air Force
Official's Role
Study Director
Facility Information:
Facility Name
96th Medical Group
City
Eglin Air Force Base
State/Province
Florida
ZIP/Postal Code
32542
Country
United States
Facility Name
Scott AFB
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62225
Country
United States
Facility Name
Mike O'Callaghan Military Medical Center
City
Nellis Air Force Base
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan on sharing data
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Links:
URL
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5580
Description
General Hospital and Personal Use Therapeutic Devices

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Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

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